FDA Device recall Z-1518-2013
TX1 Tissue Removal System disposable handpieces
- FDA Device
- Class II
- terminated
- Published 2013-06-19
On 2013-06-19 the FDA classified a Class II recall of TX1 Tissue Removal System disposable handpieces by American Optisurgical, citing american Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1518-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-30 |
| Published | 2013-06-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | American Optisurgical |
| Distribution | US |
Product
TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Reason
American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.
Identifiers
| code_info | Lot Numbers: 00312-07, 00713-06, 00912-01, 01813-02, 02413-04, 03113-02, 04213-01, 05113-01, 05113-02, 05512-…Lot Numbers: 00312-07, 00713-06, 00912-01, 01813-02, 02413-04, 03113-02, 04213-01, 05113-01, 05113-02, 05512-03, 05713-03, 06313-05, 06512-08, 06513-02, 07213-04, 07912-06, 08212-07, 09412-03, 11412-06, 11612-05, 12912-04, 14512-07, 15312-03, 16412-07, 17412-01, 18712-06, 19812-13, 20212-03, 21412-03, 22212-03, 23412-06, 24112-06, 24212-04, 24912-13, 25712-01, 26912-01, 27712-05, 28512-03, 28912-03, 29612-01, 30512-02, 31112-05, 32112-03, 33112-01, 34712-05, 36612-01 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1518-2013%22
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